Clinical Evaluation of Systane® Balance in Dry Eye Subjects

Clinical Evaluation of Systane® Balance on Corneal Staining in Indian Subjects With Dry Eye

The purpose of this study is to evaluate the efficacy and safety of Systane® Balance following 90 days of QID (4 times/day) dosing among Indian subjects with dry eye.

This study was conducted in India.

Inclusion Criteria:

• Sign informed consent and willing and able to attend all study visits;
• Dry eye in both eyes diagnosed by an ophthalmologist;
• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Women of childbearing potential who are pregnant or breastfeeding;
• Any medical condition (systemic or ophthalmic) that may preclude the safe administration of test article or safe participation in the study;
• Ocular surgery or ocular trauma requiring medical or pharmacological treatment within 1 year of Screening;
• Use of topical ocular prescription or non-prescription medications, RESTASIS or topical ocular steroids within 14 days of Screening;
• Use of any artificial tears/gels/lubricants/rewetting drops within 4 hours of Screening;
• Contact lens wear within 1 week of Screening and/or unwillingness to discontinue contact lens wear for the duration of the study;
• Other protocol-specified exclusion criteria may apply.